MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-07-12 for ACCESS? FERRITIN 33020 manufactured by Beckman Coulter.
[3649713]
The affiliate reported the customer alleged erroneously low ferritin results for one acute lymphatic leukemia patient, over six successive days, involving the access ferritin used in conjunction with unicel dxi 800 access immunoassay systems (serial numbers (b)(4)). The first six results, obtained from (b)(6) 2013, were all elevated over the upper end of the 95% confidence interval of the normal range (306. 8 ng/ml for healthy adult females and 336. 2 ng/ml for healthy adult males). On (b)(6) 2013, the customer realized that these samples were "hooking" back in to the reportable range of the ferritin assay which is up to 1,500 ng/ml. Upon appropriate dilution and analysis, the results on the retrospective samples were determined to be approximately 100 fold higher in concentration, ranging from greater than 150,000 ng/ml to 112,565 ng/ml. Samples, collected on (b)(6) 2013, were diluted appropriately with results of 119,227 ng/ml to 73,817 ng/ml. The customer stated the patient was being treated for t-cell acute lymphatic leukemia (t-all). The patient? S condition deteriorated and the physicians suspected hemophagocytic lymphohistiocytosis (hlh). According to the reporting hospital, "at this suspicion it is recommended to analyze ferritin (which shall be elevated) and liver enzymes. " as these levels are normally elevated in hlh-patients, the reported low ferritin results puzzled the physicians and may have delayed treatment for hlh, according to the customer. The customer informed beckman coulter on (b)(6) 2013 that the patient expired on (b)(6) 2013. No instrument or ferritin quality control (qc) performance issues were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[10994890]
Service was not dispatched as the customer did not question system performance. The available information reasonably suggests that the beckman coulter (bec) product may have contributed to the reported death in this incident as the customer complained that the serum ferritin levels measured were erroneously lower than expected, thereby leading the clinicians into other thoughts that may have delayed treatment. The erroneously low ferritin results were due to a "hook" effect that can occur in immunoassays when the patient sample has extremely high quantities of the material being measured. Consequently, there is no evidence to reasonably suggest a reagent malfunction. Bec's ferritin instructions for use (ifu) limitations of the procedure section states, "the access ferritin assay does not demonstrate any "hook" effect up to 40,000 ng/ml (ug/l)". The final values upon dilution were all above the threshold of 40,000 ng/ml. Based on the available information from the reporting facility and per chief medical officer at bec, hlh is a life-threatening complication with grave prognosis. Hence, it appears likely that the patient death was incidental. The customer also confirmed that the ferritin results might not have changed the outcome for the severely ill patient. No single diagnostic criterion is sufficient to make the diagnosis of hlh but a highly elevated serum ferritin along with four other criteria is strongly indicative of this condition. Ferritin concentrations greater than 500 ng/ml were 100 percent sensitive for hlh in a retrospective review of ferritin concentrations of more than 500 ng/ml over a 2-year period. Note: the high dose hook effect refers to measured levels of antigen displaying a significantly lower absorbance than the actual level present in a sample. This appears when a simultaneous immunoassay assay is saturated by a very high concentration of sample antigen binding to all available sites on both the solid phase antibody as well as the detection antibody and thereby preventing the sandwich-formation. The antigen-saturated detection antibodies in solution will be washed off giving a falsely low signal. A "hook" is observed in the curve when data are plotted as a signal versus antigen concentration. References: (1) fischer a. Chapter 316. Primary immune deficiency diseases. In: longo dl, fauci as, kasper dl, hauser sl, jameson jl, jameson jl, loscalzo j, eds. Harrison's principles of internal medicine. 18th ed. New york: mcgraw-hill; 2012. Http://www. Accessmedicine. Com/content. Aspx? Aid=9106595. Accessed july 10, 2013. (2) access medicine - table 72-5; diagnosis of hlh (3) mcclain kl, allen ce. Chapter 72. Inflammatory and malignant histiocytosis. In: prchal jt, kaushansky k, lichtman ma, kipps tj, seligsohn u, eds. Williams hematology. 8th ed. New york: mcgraw-hill; 2010. Http://www. Accessmedicine. Com/content. Aspx? Aid=6138881. Accessed july 10, 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020879-2013-00007 |
| MDR Report Key | 3224647 |
| Report Source | 01,05,06 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-06-04 |
| Date Mfgr Received | 2013-06-26 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER IRELAND |
| Manufacturer Street | MERVUE BUSINESS PARK |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? FERRITIN |
| Generic Name | RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN |
| Product Code | JMG |
| Date Received | 2013-07-12 |
| Model Number | NA |
| Catalog Number | 33020 |
| Lot Number | 270217 |
| ID Number | NA |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-07-12 |